The extraarticular symptoms influence ACR response in the treatment of rheumatoid arthritis with biomedicine: a single-blind, randomized, controlled, multicenter trial in 194 patients.

OBJECTIVE The extraarticular symptoms are important in the pattern differentiation of traditional Chinese medicine (TCM), and the present study is designed in an attempt to find the associations between the extraarticular symptoms and American College of Rheumatology (ACR) Response in 194 cases of rheumatoid arthritis (RA) treated with biomedicine. METHODS The data were obtained from a randomized clinical trial. One hundred ninety-four RA patients were treated with the biomedical therapy (diclofenec, methotrexate and sulfasalazine). ACR20 response in 24 weeks was used for the efficacy evaluation. Eighteen symptoms (including 13 extraarticular symptoms) that TCM practitioners focus on were collected for exploration on the association between the symptoms and the efficacy of the biomedical therapy with association rules method. RESULTS After 24 weeks, a total of 135 patients receiving biomedicine had achieved an ACR20 response. The association rules analysis on each symptom showed that soreness in the waist was more associated with ACR20 response, but with lower support (selected sample size based, 20.10% and 14.95% respectively); cold intolerance and cold joint were found to be associated with ACR20 response with higher support (48.97% and 53.61% respectively), and the confidences (predicted effective rate) were 73.08% and 71.23% respectively. The associations between combination of symptoms (among them, there was at least one extraarticular symptom) and ACR20 response indicated that cold intolerance or cold joint with higher confidence and support were the most important extraarticular symptoms. CONCLUSION The RA patients with "cold intolerance" and "cold joints", which are the extraarticular symptoms that TCM practitioners focus on, may show higher ACR20 response when treated with the biomedical approach.